U.S. patent number 6,491,624 [Application Number 09/647,949] was granted by the patent office on 2002-12-10 for device for peroperative exploration of a cardiovascular system.
Invention is credited to Houari Lotfi.
United States Patent |
6,491,624 |
Lotfi |
December 10, 2002 |
Device for peroperative exploration of a cardiovascular system
Abstract
A device for exploration of the cardiovascular system of human
or animal bodies includes a generally transparent blind tube
delimiting a cavity in which can be disposed an optical display
device, the open end of the tube being shaped to be ensleeved
axially in a sealed manner in the passage of an artery or of a vein
having first been at least partially sectioned such that the cavity
of the tube in the interior of the artery or of the vein form a
common chamber at least partially closeable by a cardiac valve. The
tube, maintained in ensleeved position by a suitable securement
member, includes at least one supplemental opening for the
introduction into the cavity of the tube of a physiological liquid
under pressure.
Inventors: |
Lotfi; Houari (49100 Angers,
FR) |
Family
ID: |
27253424 |
Appl.
No.: |
09/647,949 |
Filed: |
November 20, 2000 |
PCT
Filed: |
April 06, 1999 |
PCT No.: |
PCT/FR99/00790 |
371(c)(1),(2),(4) Date: |
November 20, 2000 |
PCT
Pub. No.: |
WO99/51169 |
PCT
Pub. Date: |
October 14, 1999 |
Foreign Application Priority Data
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Apr 6, 1998 [FR] |
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98 04220 |
Jun 29, 1998 [FR] |
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98 08370 |
Oct 5, 1998 [FR] |
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98 12466 |
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Current U.S.
Class: |
600/114; 600/109;
600/160; 623/921; 623/922 |
Current CPC
Class: |
A61F
2/2472 (20130101); Y10S 623/921 (20130101); Y10S
623/922 (20130101) |
Current International
Class: |
A61F
2/24 (20060101); A61F 002/24 () |
Field of
Search: |
;128/898,899
;600/101,109,114,160 ;623/913,921,922 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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WO-A-92 12690 |
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Aug 1992 |
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WO |
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WO-A-97 25004 |
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Jul 1997 |
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WO |
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Primary Examiner: Rivell; John
Assistant Examiner: Krishnamurthy; Ramesh
Attorney, Agent or Firm: Young & Thomspon
Claims
What is claimed is:
1. A device for the per-operative exploration of an organ of a
cardiovascular system of a human or animal body, comprising: a
hollow body made of a sealed material, said hollow body defining a
cavity for an optical display device, said cavity being open into
and/or into the vicinity of an open end of the hollow body, the
open end of the hollow body being introduced through an opening of
an organ to be explored and being shaped to directly or by means of
at least one suitable securement member to connect in a
substantially sealed manner the hollow body to the organ such that
the cavity of the hollow body and an interior of the organ to be
explored form a common chamber at least partially closeable by a
closure member present in the organ to be explored, the hollow body
comprising, opposite the open end of the hollow body, at least one
supplemental opening that opens into said cavity for the
introduction into said cavity of a liquid under pressure to
increase a pressure prevailing within the organ so as to facilitate
the exploration.
2. The exploration device according to claim 1, wherein the hollow
body comprises, over its periphery, in its region of connection to
the organ to be explored, at least one continuous or discontinuous
external circumferential swelling and/or recess to form
respectively at least one enlarged or recessed portion, which
enlargement and/or recess coacts with the securement member to
ensure a sealed ensleeving of the hollow body in the organ to be
explored.
3. The device according to claim 1, wherein the securement member
presses on at least a portion of walls of the organ to be explored
against sidewalls of the hollow body.
4. The exploration device according to claim 3, wherein the
securement member is shaped as an elastically deformable open ring
or a belt.
5. The exploration device according to claim 1, wherein the hollow
body comprises, at its periphery, a ring slidably mounted on the
hollow body the ring being applied against an external periphery of
an opening in a ventricle and ensuring, in coaction with a
ventricle wall, a substantially sealed connection between the
hollow body and the ventricle.
6. The exploration device according to claim 1, wherein the hollow
body comprises a further supplemental opening whose edges are
secured to a pocket at least partially transparent and shaped to be
able to be disposed within the cavity, this at least partially
transparent pocket serving for the reception of the optical display
device, and isolating said display device from other contents of
said cavity.
7. The exploration device according to claim 1, wherein the optical
display device comprises a camera orientable by means of an arm
projecting outside said body.
8. The exploration device according to claim 1, wherein said body
comprises at least two of said supplemental opening, at least one
of the supplemental openings being provided on a lateral wall of
the body, said supplemental openings comprising closure
members.
9. The exploration device according to claim 1, further comprising
means for measuring the pressure prevailing within said common
chamber to determine a quantity of liquid to be introduced into
said chamber.
10. The exploration device according to claim 1, wherein the hollow
body comprises at least one elbow.
11. A device for per-operative exploration of an organ of a human
or animal body, the device comprising: a hollow body defining a
cavity, an open end of said cavity being adapted to be placed,
using a connection device, into an opening of an organ to be
explored so that an interior of the organ and the cavity form a
common chamber, the connection device including a securement member
placed so as to connect the hollow body and the organ in a
substantially sealed manner, the hollow body comprising at least
one supplemental opening opposite to the open end for introducing a
liquid under pressure into an interior of the organ to be explored
so as to facilitate exploration of the organ.
Description
BACKGROUND OF THE INVENTION
The present invention relates to a device for the per-operative
exploration of organs such as veins or arteries or ventricles, of
the cardiovascular system of human or animal bodies, in particular
to determine the state of functionality of the cardiac valves or
valvules.
The most serious operations, because of their consequences for the
rest of the human or animal body, require a systematic control of
the quantity of surgical intervention. Thus, in the case of cardiac
interventions, after aortaplasty or replacement of the aortic valve
by a homograft, a pulmonary autograft or a heterograft without a
prop, it is necessary, to appreciate the quality of the surgical
work, to provide a transesophagal echograph (TOE) after reclosing
the aortotomy and stopping the extracorporeal circulation (ECC).
Because of this, when there is detected an imperfection in the work
of the surgeon, it is necessary to provide a new aortotomy and to
replace an ECC device.
SUMMARY OF THE INVENTION
The object of the present invention is thus to provide a device for
per-operative exploration of veins, arteries or ventricles of the
cardiovascular system of human or animal bodies, which permits
appreciating, at any moment during the procedure, the quality of
the work carried out by the surgeon.
Another object of the present invention is to provide a device for
per-operative exploration of veins or arteries or ventricles of the
cardiovascular system of the human or animal body, whose design
permits testing the sealing of the valvuloplasties, of the
prostheses, of the native valves, to appreciate the quality of the
coaptation of the sigmoids and to detect and analyze an
imperfection of a prop so as to remedy it immediately.
To this end, the invention has for its object a device for
per-operative exploration of organs, such as veins or arteries, in
particular of the aorta or ventricles, of the cardiovascular system
of the human or animal body, in particular to appreciate the
condition of operation of the cardiac valves, or the valvules, or
the stents, or the prosthetic tubes, characterized in that it is
constituted by an elongated hollow body, such as a tube, made of a
sealed material, preferably transparent, said body delimiting a
cavity in which can be disposed, permanently or temporarily,
optical display means, such as a camera, said cavity being open
into and/or into the vicinity of, one end of the hollow body, this
open end of the hollow body, adapted to be introduced through an
opening of the organ to be explored, being shaped to be able,
directly or by means of at least one suitable securement member, to
connect, in a substantially sealed manner, the body to the organ,
such that the cavity of the hollow body and the interior of the
organ form a common chamber at least partially closeable by a
cardiac valve, a valvual and/or by a closure member provided in the
organ, this hollow body comprising, preferably opposite the open
end of the body, at least one supplemental opening opening into
said cavity of the body for the introduction into said cavity of
the hollow body a liquid under pressure permitting, in the
condition introduced into the body in an organ, an increase of the
pressure prevailing within the organ so as to facilitate the
possible functional exploration of it.
Thanks to this design of the device, it is possible, at any moment
during the intervention and in several seconds, to verify the
quality of the work of the surgeon, to test the possible sealing of
the cardiac valves, or the valvules, the position of the valves, or
of the valvules, by the naked eye.
Moreover, because of this design, such a device does not
necessarily require, for the surgeon, to modify the aortotomy as it
is conventionally practiced. Thus, in the case in which the aorta
is at least partially sectioned, the hollow body is simply
ensleeved axially within the arterial passage or the vein.
According to a first preferred embodiment of the invention, the
hollow body comprises, over its periphery, in the region for
connection to an organ to be explored, at least one continuous or
discontinuous external circumferential swelling and/or recess,
arranged to form respectively at least one portion of a swelling or
trough, which swelling and/or trough coact with the securement
member of the device to ensure a connection, in particular a sealed
ensleeving of the body in the organ to be explored and to prevent
any sliding of the body out of the organ to be explored.
According t o a second embodiment of the invention, the hollow body
comprises over its periphery a ring mounted slidably on said body
to come, when the open end of the hollow body is introduced through
an opening of a ventricle within this latter, to bear against the
external periphery of the opening provided in the ventricle and to
ensure, in cooperation with the walls of the ventricle, a
substantially sealed connection between the hollow body and the
ventricle.
BRIEF DESCRIPTION OF THE DRAWINGS
The invention will be better understood from a reading of the
following description of examples of embodiment, with reference to
the accompanying drawings, in which:
FIG. 1 shows a schematic perspective view of the device, which is
the object of the invention, in a position installed on an artery
constituted by the aorta;
FIG. 2 shows another perspective view of the device, according to
the invention, in a fixed position in a sealed manner on the
aorta;
FIG. 3 shows a perspective view of another embodiment of the
device, and
FIG. 4 shows a bottom view of a securement member of the device to
an artery.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
The exploration device, according to the invention, is a
per-operative exploration device permitting at any time, in the
course of a surgical intervention, to explore the veins, the
arteries, in particular the aorta, or the ventricles, of the
cardiovascular system of the human or animal body and to determine
in particular the state of operation of the cardiac valves, the
valvules, or the condition of stents, or of prosthetic tubes,
positioned in the arteries.
More and more, surgical operations carried out are complex
operations. Such surgical interventions, in particular the
aortaplasties, require immediately being able to control the
effectiveness and the sealing of this plasty to as to obtain the
best results. It is thus necessary to be able to test the sealing
of the valvular replacement whether in the pericardium, with a
homograft, a heterograft, a biological or mechanical prosthesis,
the pressure which acts directly on the aortic valves in the closed
position, the position of the valves to the naked eye, etc. The
per-operative exploration device according to the invention permits
such tests. In the examples of embodiments described below, this
device will be more particularly described in the field of its
introduction into the veins or arteries. However, it may similarly
be introduced into a ventricle of the heart.
To do this, this exploration device is constituted by an elongated
hollow body 1, such as a tube, made of a sealed material, generally
transparent and preferably semirigid. Generally, the device
comprises means 15 for measuring the pressure prevailing within a
chamber 6 common to the hollow body cavity 1 and to the interior of
the organ 5 to be explored, to determine the quantity of liquid 10
to be introduced into this chamber 6 so as to obtain, within this
chamber 6, a physiologically acceptable pressure. This body 1
defines a closed cavity 2 in which can be disposed, permanently or
temporarily, optical display means 3, such as a camera. This cavity
2 is open to, or into the vicinity of, an end of the hollow body 1
thanks to lateral openings (not shown) or axial openings 4 provided
at the end of this body 1. This open end 4 of the hollow body 1 is
shaped to be introduced through an opening 22 provided in the organ
to be explored. This opening 22 in the organ can be provided by
sectioning at least partially the artery or the vein such that the
open end 4 of the body 1 is thus ensleeved axially within the
passage of the organ and connected sealingly to this latter. In
this case, on the contrary, in which the vein or the artery, and
particularly the aorta, has an incision provided on its lateral
wall, the open end of the body is introduced radially into the
artery or the vein before being connected in a sealed manner to
this latter. Thus, in the case of the example shown in FIG. 1, the
artery 5 in which will be ensleeved the hollow body 1, is the
aorta. Because of its design, the device according to the invention
does not require the surgeon to modify his work during practice of
the aortotomy. Thus, in the case for example of a cardiac
intervention on the aortic valve, the aortotomy practiced is a
circumferential anterior aortotomy sparing the rear surface of the
aorta. The device according to the invention permits respecting
this aortotomy.
In its simplest version, the body 1 is constituted by a simple tube
of the semi-rigid test tube type, generally cylindrical, if desired
elbowed, open at or near one end and closed at its other end. When
the end of the body is sufficiently introduced into the artery, or
the vein, or the ventricle, which is to say beyond the openings of
the cavity, the cavity of the body 1 and the interior of the organ
5 form a common chamber 6. According to the emplacement at which
has been provided the sectioning or an incision of the organ, this
common chamber can be partially closeable by a cardiac valve 7, by
a valvule and/or by at least one closure member provided in the
organ. In this case, this closure member constitutes one of the
elements of the device. This closure member can be constituted by a
clamp or by a simple balloon disposed in the artery or in the vein
downstream of the section of the artery or of the vein to be
observed taken in the direction of introduction of the body into
the artery or the vein.
In the example shown in the figures, this common chamber 6 is
closed by the aortic valve 7, the object being in this case to
verify the operation of this latter.
The hollow body 1 is maintained in substantially sealed connected
position in the organ 5 by means of a securement member 6, such as
a member pressing at least a portion of the walls of the organ 5
against the sidewalls of the hollow body 1. To guarantee the
solidity and sealing of this connection, the hollow body 1
comprises about its periphery, in its region Z1 of connection in an
organ 5, at least one continuous or discontinuous external
circumferential swelling 11 or recess 12 arranged to form
respectively at least one portion of an enlargement or a trough,
which enlargement and/or trough coact with the securement member 8
of the device to ensure a connection, in particular a sealed
ensleeving of the body 2 in the organ 5 and to prevent any sliding
of the body 2 out of the organ 5. Thus, in the example shown in
FIG. 1, the hollow body 1 comprises over its periphery a continuous
external circumferential swelling 11. This swelling 11 can be
provided by at least one ring connected to the body or made of a
single piece with said hollow body 1. Conversely, in the example
shown in FIG. 3, the hollow body 1 comprises about its periphery a
continuous external circumferential recess 12 providing a trough
about said body 1. Generally, in the case of a continuous recess,
this recess has a width of about 3 mm and occupies a third of the
thickness of the wall of the hollow body 1. In the other solution
consisting in connecting for example a cylindrical ring to provide
a circumferential external swelling about the periphery of the
hollow body 1, there will be preferably selected a ring transparent
to radiation. It is also possible to combine the two solutions. In
this case, the hollow body 1 comprises, adjacent its free end, a
continuous circumferential recess adapted to receive a cylindrical
ring whose external surface is of a shape complementary to that of
the recess. This ring will in this case preferably have a rigid
consistency, and be non-slip and atraumatic. The choice of the
swelling or the recess will be a function of the physical
characteristics of the organ of the patient.
The securement member 8 used to ensure the maintenance of this
connection can be of any shape. Thus, the securement member 8 of
the organ 5 to the body 1 can have the shape of a resiliently
deformable open ring. This securement member 8 of the organ 5 to
the body 1 can also have the shape of a belt, as shown in FIG. 4.
This belt can thus, by way of example, be constituted by a woven
strip of substantially rectangular shape. The internal surface of
this belt has a concavity over all its length. Each of the two free
longitudinal edges 18 of this belt is folded back on itself to
delimit a sleeve within which is introduced a cord 19. At the free
ends of the cord 19 is secured a woven strip 20, generally
self-gripping. This belt also comprises on its back a self-gripping
strip adapted to coact with self-gripping strips 20 disposed in
prolongation of the ends of the cord 19 to permit, after
positioning the belt about the walls of the organ and tightening
the cord, a holding in position of this latter. The concavity of
the belt permits matching perfectly the swelling of the hollow body
1 when this swelling exists. Such a belt shows the advantage of
being able to be fixed in several seconds about the organ and to
ensure, in spite of everything, good sealing of the connection.
Another example of securement member 8 has also been shown in FIG.
3. In this case, this securement member is constituted by a simple
periaortic lace. Finally, it is to be noted that other securement
members permitting connection by screwing or the like can be used.
Furthermore, in the case in which the body 1 is introduced through
an opening provided in the ventricle, a securement member is not
necessary to ensure a substantially sealed connection between the
body and the ventricle because the natural construction of the
walls of the ventricle can ensure this sealing.
The hollow body 1 also comprises at least one supplemental opening
9A, 9B opening into said cavity 2 of the body 1 for the
introduction into said cavity of the hollow body 1 of a liquid 10
under pressure permitting an increase of the pressure prevailing
within the organ 5 so as to facilitate the possible desired
functional operation of it. Thus, in the example shown in FIG. 1, a
pressure body contains a liquid 10 under pressure, this liquid
being adapted to be constituted for example by a serum or
cardioplegic liquid. A flexible conduit 21 serves as a connection
conduit between the open end of this liquid pocket under pressure
and the opening 9A of the hollow body 1. Obviously, the openings
9A, 9B can have various shapes as a function of the shape of the
connection conduit. In particular, the edges of these openings 9A,
9B can project outside the body 1.
Generally speaking, the hollow body 1 comprises at least two
openings 9A and 9B for the introduction of a liquid under pressure
into the cavity 2 of the body 1. At least one of the openings is
provided on a side wall of the body 1 so as to permit the use of
the device in particular for young patients. Moreover, the openings
9A and 9B comprise closure members (not shown). It is to be noted
that one of the openings can also be used for the connection of the
body, and in particular of the cavity of the body, to a suction
device.
The device also comprises means 15 for measuring the pressure
prevailing within said common chamber 6 to determine the quantity
of liquid 10 to be introduced into this chamber 6 so as to obtain,
within said chamber 6, a physiologically acceptable pressure.
Generally speaking, these means 15 are constituted by a manometer
connected to a probe. In a particular embodiment of the invention,
the probe of the means 15 for measuring the pressure is introduced
into the hollow body 1 through a supplemental opening 17 provided
in or adjacent the upper end of said hollow body 1, as shown in
FIG. 2.
The optical display means 3 can themselves be single use means
positioned in the cavity 2 of the hollow body 1, adjacent the open
end 4 of the body 1, during production of said body 1. These means
are thus constituted by a camera orientable by means of an arm
projecting outside said body.
In another embodiment of the optical display means 3, such as shown
in FIG. 1, the hollow body comprises a supplemental opening 13
whose edges are secured to a generally flexible pocket 14 by
partially transparent means shaped to be able to be disposed within
the cavity 2 of said body 1. This at least partially transparent
generally flexible pocket 14 serves for the reception of optical
display means 3, such as a camera or a fibroscope, and isolates
said display means 3 from the rest of the contents of said cavity 2
of the hollow body 1. It is thus possible to reuse the optical
display means.
To use such a device, one proceeds for example in the following
manner. The surgeon measures in a first step the internal diameter
of the organ which must be explored. He then selects a hollow body
1 whose external diameter is substantially equivalent to that of
the organ. The open end of the hollow body is introduced within the
organ, for example the aorta, as in FIG. 1. Generally speaking,
when the selected organ is the aorta, the hollow body 1 is
positioned on the aortic artery 5, such that the connection zone of
the open end 4 of the hollow body 1 to the aorta is provided in the
sinotubular region of the ascending aorta. This is according to the
example shown in FIG. 1.
Aortotomy is carried out as is conventional for such operations.
The results of this aortotomy are more particularly visible in FIG.
2. The open end 4 of the hollow body 1 is introduced into the
passage of the aorta such that the aorta receives a swelling or a
recess of the hollow body when this latter exists and extends
substantially above this swelling or this recess, this excess being
generally of the order of 4 mm.
Once the hollow body 1 is positioned in the passage of the organ to
be explored, the securement member 8 is secured. After securement
and gripping of this securement member, a source of liquid 10 under
pressure is connected for example through to the opening 9B located
on the lateral surface of the hollow body thanks to a tube 21. A
probe of the pressure manometer 15 is introduced through a second
opening 17 of the hollow body 1 or directly into the root of the
organ to be explored. At the same time, optical display means are
emplaced, in particular a camera or a fibroscope, through the third
opening 13 of the hollow body 1 such that these optical means
extend within the flexible pocket 14. The injection of fluid 10
into the common chamber 6 can then commence. This injection is
provided such that the flow rate is progressively increased. Thanks
to the images taken in real time by the optical display means and
if desired to the transparency of the body, it becomes easy to
oversee the flow of the liquid, the position of the fibroscope and
the movements of the artificial valve flaps or of the natural
valves. At the same time, thanks to the external pressure
manometer, it is easy to oversee the intra-aortic pressure which
simulates the physiological diastolic pressure. Because of the ease
of mounting and unmounting the device, this operation of
controlling, exploring and testing can be carried out several times
until a sealing is obtained conforming to a natural functioning of
the valves. Such a device thus permits overcoming immediately small
faults of suturing, of repair, of mounting, and preventing any
post-operative aortic leakage, etc. Moreover, such a device
permits, on natural valves, to survey perfectly the closure of the
sigmoids and then the stretching of the Valsalva sinuses, to the
extent that the pressure increases and, finally, the coaptation of
the aortic sigmoids and of the mitral, tricuspid and pulmonary
valves.
It is to be noted that, to carry out a complete exploration, it
will sometimes be necessary to visualize simultaneously also the
ventricular surface of the aortic valve, this visualization taking
place simply by means of a fibroscope introduced into the point of
the left ventricle. Similarly, for damaged valves, the device
permits taking account of the absence of the tensioning of the
Valsalva sinuses because of a leakage which can be perfectly
localized when a fibroscope is introduced into the point of the
left ventricle. Finally, for repaired valves, the qualities and
defects of the different mountings can be appreciated.
* * * * *